Improving Antimicrobial-Prescribing in Emergency Departments
Primary Purpose
Anti-Bacterial Agents, Respiratory Tract Infections
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Audit-and-feedback
Sponsored by
About this trial
This is an interventional health services research trial for Anti-Bacterial Agents
Eligibility Criteria
Inclusion Criteria:
--An ED provider at one of the intervention or control sites.
Exclusion Criteria:
--An ED provider who sees less than 100 patients in the ED per year.
Sites / Locations
- Richard Roudebush VAMC
- Sioux Falls VA
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Audit-and-feedback
Control
Arm Description
The experimental arm will consist of Emergency Department providers who do receive the intervention.
The control arm will consist of providers who do not receive the intervention.
Outcomes
Primary Outcome Measures
Percentage of Patient-visits Prescribed an Antimicrobial at Their ED Visit
This outcomes is defined as the total number of antimicrobial-prescribing visits divided by the total number of patient-visits. This metric will be calculated on a monthly basis for each site (2 intervention, 2 control). It will be calculated during the baseline and intervention periods. Therefore, each site will contribute 24 data points.
Secondary Outcome Measures
Percentage of Patient-visits Prescribed a Late Antimicrobial Prescription More Than 24 Hours After But Within 30 Days of Their ED Visit
Late antimicrobial prescription is defined as the prescription of an (additional) antimicrobial by any provider more than 24 hours after but within 30 days of the patient's ED visit.
Percentage of Patient-visits Who Were Hospitalized More Than 24 Hours After But Within 30 Days of Their ED Visit
Hospitalization is defined as the need for hospitalization for any indication at a VA-facility more than 24 hours after but within 30 days of the patient's index visit to the ED.
Percentage of Patient-visits Who Died More Than 24 Hours After But Within 30 Days of Their ED Visit
Death is defined as all-cause death more than 24 hours after and within 30-days of the patient's ED visit.
Percentage of Patient-visits Who Underwent Clostridium Difficile Testing More Than 24 Hours After But Within 30 Days of Their ED Visit
Clostridium difficile testing is defined as a laboratory test for Clostridium difficile ordered more than 24 hours after but within 30-days of the patient's ED visit.
Percentage of Patient-visits Who Received Guideline Concordant Antimicrobial Management
This outcome was assessed using blinded manual chart reviews in a randomly selected sample of patients that met inclusion criteria, as outlined in our study protocol. For this reason, the denominators for this outcome will not match the patient counts for the other outcomes. If a patient received an antimicrobial when indicated or did not receive an antimicrobial when not indicated, the patient was deemed to have received guideline-concordant management. During the baseline period, 497 charts were randomly selected for review, and 480 ultimately underwent adjudication. During the intervention period, 576 charts were randomly selected for review, and 455 underwent adjudication.
Percentage of Patient-visits Prescribed an Antibiotic at Their ED Visit
This outcomes is defined as the total number of antibacterial-prescribing visits divided by the total number of patient-visits. This metric will be calculated on a monthly basis for each site (2 intervention, 2 control). It will be calculated during the baseline and intervention periods. Therefore, each site will contribute 24 data points.
Full Information
NCT ID
NCT03349567
First Posted
November 17, 2017
Last Updated
April 2, 2021
Sponsor
Iowa City Veterans Affairs Medical Center
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT03349567
Brief Title
Improving Antimicrobial-Prescribing in Emergency Departments
Official Title
The Use of Audit-and-Feedback to Improve Antimicrobial-Prescribing in Emergency Departments: a Quasi-experimental Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
October 9, 2018 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
October 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Iowa City Veterans Affairs Medical Center
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Antimicrobial resistance is one of today's most urgent public health problems. One of the most important strategies to slow the spread of antimicrobial resistance is the promotion of judicious antimicrobial use. There are tremendous opportunities to reduce unnecessary antimicrobial-prescribing, particularly in Emergency Departments (EDs). In this study, the investigators will work collaboratively with ED providers in the Veterans Health Administration (VHA) to reduce unnecessary antimicrobial use. Academic-detailing and an audit-and-feedback intervention will be implemented, and the study will assess how overall antimicrobial-prescribing changes once these interventions are performed. ED providers will be shown how their antimicrobial-prescribing compares to their peers, thereby encouraging them to consider their professional reputation when making prescribing decisions. To assess the impact of this intervention, the study will monitor providers' antimicrobial-prescribing behavior through an automated metric, i.e. number of antimicrobial prescriptions per number of patient-visits. To assess changes in the appropriateness of antimicrobial-prescribing, the study team will also perform manual chart reviews and compare prescribing decisions to published guidelines.
Detailed Description
Using a quasi-experimental design, the study team will work collaboratively with ED providers in the Veterans Health Administration (VHA) to improve antimicrobial-prescribing. Academic-detailing and an audit-and-feedback intervention will be implemented. Through audit-and-feedback, providers will be shown how their antimicrobial-prescribing compares to their peers, thereby encouraging them to consider their professional reputation when making prescribing decisions.
The study will use a pretest-posttest design (quasi-experimental design with a non-equivalent control group) to assess the effect of our pilot intervention at 2 participating EDs and 2 control EDs. For each ED, the pretest period will be the 12 months prior to the intervention. The intervention itself will last 12 months.
There will be an estimated 30 ED providers at the 2 study sites and 30 ED providers at the 2 control sites. Only antimicrobial prescriptions to patients discharged from the ED will be evaluated.
The primary outcome will be antimicrobial-prescribing volume adjusted for the total number of patient-visits. Secondary outcomes include the frequency of guideline-discordant antimicrobial-prescribing and adverse events.
At the conclusion of the pilot trial, a quasi-experimental interrupted time-series (ITS) analysis will be performed to assess the change in monthly antimicrobial usage for the 2 intervention sites combined and the 2 control sites combined. The time frame for this ITS analysis will be the one-year prior to the pilot trial's initiation through the trial's 1-year intervention period for a total of 24 months. In addition, a multivariable analysis will be performed to identify predictors of guideline-discordant therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anti-Bacterial Agents, Respiratory Tract Infections
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Audit-and-feedback
Arm Type
Experimental
Arm Description
The experimental arm will consist of Emergency Department providers who do receive the intervention.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control arm will consist of providers who do not receive the intervention.
Intervention Type
Behavioral
Intervention Name(s)
Audit-and-feedback
Other Intervention Name(s)
Academic detailing
Intervention Description
We will monitor the antimicrobial-prescribing of providers in the experimental arm. Our study team will meet with providers in the experimental arm to provide guidance on optimal antimicrobial-prescribing. We will provide personalized feedback to providers in the experimental arm once every quarter.
Primary Outcome Measure Information:
Title
Percentage of Patient-visits Prescribed an Antimicrobial at Their ED Visit
Description
This outcomes is defined as the total number of antimicrobial-prescribing visits divided by the total number of patient-visits. This metric will be calculated on a monthly basis for each site (2 intervention, 2 control). It will be calculated during the baseline and intervention periods. Therefore, each site will contribute 24 data points.
Time Frame
This outcome will be calculated every month during the baseline and intervention periods. An interrupted time-series analysis will be performed to evaluate how this monthly percentage changed after the intervention period began.
Secondary Outcome Measure Information:
Title
Percentage of Patient-visits Prescribed a Late Antimicrobial Prescription More Than 24 Hours After But Within 30 Days of Their ED Visit
Description
Late antimicrobial prescription is defined as the prescription of an (additional) antimicrobial by any provider more than 24 hours after but within 30 days of the patient's ED visit.
Time Frame
For both intervention and control sites, the outcome will be reported as a monthly median, which is calculated across the 12 baseline and the 12 intervention months.
Title
Percentage of Patient-visits Who Were Hospitalized More Than 24 Hours After But Within 30 Days of Their ED Visit
Description
Hospitalization is defined as the need for hospitalization for any indication at a VA-facility more than 24 hours after but within 30 days of the patient's index visit to the ED.
Time Frame
For both intervention and control sites, the outcome will be reported as a monthly median, which is calculated across the 12 baseline and the 12 intervention months.
Title
Percentage of Patient-visits Who Died More Than 24 Hours After But Within 30 Days of Their ED Visit
Description
Death is defined as all-cause death more than 24 hours after and within 30-days of the patient's ED visit.
Time Frame
For both intervention and control sites, the outcome will be reported as a monthly median, which is calculated across the 12 baseline and the 12 intervention months.
Title
Percentage of Patient-visits Who Underwent Clostridium Difficile Testing More Than 24 Hours After But Within 30 Days of Their ED Visit
Description
Clostridium difficile testing is defined as a laboratory test for Clostridium difficile ordered more than 24 hours after but within 30-days of the patient's ED visit.
Time Frame
For both intervention and control sites, the outcome will be reported as a monthly median, which is calculated across the 12 baseline and the 12 intervention months.
Title
Percentage of Patient-visits Who Received Guideline Concordant Antimicrobial Management
Description
This outcome was assessed using blinded manual chart reviews in a randomly selected sample of patients that met inclusion criteria, as outlined in our study protocol. For this reason, the denominators for this outcome will not match the patient counts for the other outcomes. If a patient received an antimicrobial when indicated or did not receive an antimicrobial when not indicated, the patient was deemed to have received guideline-concordant management. During the baseline period, 497 charts were randomly selected for review, and 480 ultimately underwent adjudication. During the intervention period, 576 charts were randomly selected for review, and 455 underwent adjudication.
Time Frame
For the baseline and intervention periods, this outcome will be reported as the percentage of patients who received guideline-concordant management among the sample of qualifying ED visits that were randomly selected for manual chart review.
Title
Percentage of Patient-visits Prescribed an Antibiotic at Their ED Visit
Description
This outcomes is defined as the total number of antibacterial-prescribing visits divided by the total number of patient-visits. This metric will be calculated on a monthly basis for each site (2 intervention, 2 control). It will be calculated during the baseline and intervention periods. Therefore, each site will contribute 24 data points.
Time Frame
This outcome will be calculated every month during the baseline and intervention periods. An interrupted time-series analysis will be performed to evaluate how this monthly percentage changed after the intervention period began.
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
--An ED provider at one of the intervention or control sites.
Exclusion Criteria:
--An ED provider who sees less than 100 patients in the ED per year.
Facility Information:
Facility Name
Richard Roudebush VAMC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Sioux Falls VA
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Improving Antimicrobial-Prescribing in Emergency Departments
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